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POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound

Primary Purpose

Abdominal Pain, Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
point-of-care ultrasound
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Pain

Eligibility Criteria

8 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers

Exclusion Criteria:

  • History of genitourinary or pelvic anomalies (e.g. neurogenic bladder, urogenital malformation, ambiguous genitalia, Turner Syndrome, ureterocele, bladder diverticulum, imperforate hymen); history of pelvic surgery
  • Critically ill patients who are unable to consent
  • Sensation of maximal bladder fullness/need to void at time of start of the study
  • Nonverbal patients or severe cognitive or language delay

Sites / Locations

  • Hasbro Children's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

POCUS

Usual Care

Arm Description

Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.

Patients will be given consecutive IV fluid boluses until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician

Outcomes

Primary Outcome Measures

Median Fill-To-Done (FTD) Time
Median time from enrollment to successful completion of TAPUS

Secondary Outcome Measures

Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt

Full Information

First Posted
September 24, 2016
Last Updated
March 16, 2019
Sponsor
Lifespan
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1. Study Identification

Unique Protocol Identification Number
NCT02923245
Brief Title
POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound
Official Title
Point-of-Care-Ultrasound Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 5, 2016 (Actual)
Study Completion Date
November 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more quickly determine adequate bladder fullness to successfully perform transabdominal pelvic ultrasound than patient's perception of bladder fullness.
Detailed Description
Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario. This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups: Standard of care group - Patients will be given consecutive IV fluid boluses until sensation of maximum bladder fullness followed by transabdominal pelvic US performed by a radiologist or US technician. Experimental group - Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS followed by transabdominal pelvic US performed by a radiologist or US technician. Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Pelvic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POCUS
Arm Type
Experimental
Arm Description
Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients will be given consecutive IV fluid boluses until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician
Intervention Type
Other
Intervention Name(s)
point-of-care ultrasound
Primary Outcome Measure Information:
Title
Median Fill-To-Done (FTD) Time
Description
Median time from enrollment to successful completion of TAPUS
Time Frame
on same day as study enrollment
Secondary Outcome Measure Information:
Title
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
Time Frame
on same day as study enrollment
Other Pre-specified Outcome Measures:
Title
Number of Participants Receiving IV Narcotics in the Emergency Department
Time Frame
day of enrollment
Title
Total IV Fluids Given Prior to TAPUS
Time Frame
day of enrollment
Title
TAPUS Result
Time Frame
day of enrollment
Title
Disposition From ED
Time Frame
day of enrollment
Title
Inter-rater Agreement
Description
Agreement between the POCUS sonographer and the blinded reviewer
Time Frame
at close of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Girls age 8-18 presenting to the pediatric Emergency Department who need transabdominal pelvic ultrasound as determined by their treating providers Exclusion Criteria: History of genitourinary or pelvic anomalies (e.g. neurogenic bladder, urogenital malformation, ambiguous genitalia, Turner Syndrome, ureterocele, bladder diverticulum, imperforate hymen); history of pelvic surgery Critically ill patients who are unable to consent Sensation of maximal bladder fullness/need to void at time of start of the study Nonverbal patients or severe cognitive or language delay
Facility Information:
Facility Name
Hasbro Children's Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29980460
Citation
Dessie A, Steele D, Liu AR, Amanullah S, Constantine E. Point-of-Care Ultrasound Assessment of Bladder Fullness for Female Patients Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound in a Pediatric Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2018 Nov;72(5):571-580. doi: 10.1016/j.annemergmed.2018.04.010. Epub 2018 Jul 3.
Results Reference
derived

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POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound

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